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Immunomodulatory Agent
Tafasitamab + Lenalidomide/ICE for Large B-Cell Lymphoma
Phase 2
Recruiting
Led By David A Bond, MD
Research Sponsored by David Bond, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial evaluates a new treatment for large B-cell lymphoma: tafasitamab, lenalidomide, carboplatin, etoposide, and ifosfamide. It may help stop cancer cells from growing.
Who is the study for?
This trial is for adults with certain types of large B-cell lymphoma that has relapsed or hasn't responded to treatment. They must have had one prior chemo-immunotherapy, be eligible for a transplant, and able to consent. Participants need adequate organ function and no history of significant heart disease, uncontrolled infection, or other cancers that could interfere.Check my eligibility
What is being tested?
The study tests tafasitamab plus lenalidomide followed by ICE chemotherapy (carboplatin, etoposide, ifosfamide) as salvage therapy in patients suitable for transplants. Tafasitamab is an antibody against cancer cells; lenalidomide may block tumor growth; ICE kills or stops cancer cell division.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system from tafasitamab, blood disorders from lenalidomide and fatigue. The ICE regimen can cause nausea, hair loss, kidney damage and increased risk of infections due to low blood cell counts.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete remission (CR) rate
Secondary outcome measures
Incidence of adverse events
Overall response rate (ORR)
Progression free survival
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (tafasitamab, lenalidomide, ICE regimen)Experimental Treatment9 Interventions
Patients receive tafasitamab IV, lenalidomide PO, etoposide IV, ifosfamide IV and carboplatin IV on study. Patients undergo PET or CT, and undergo blood sample collection throughout the study. Patients may undergo tissue biopsy on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670
Computed Tomography
2017
Completed Phase 2
~2720
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1700
Etoposide
2010
Completed Phase 3
~2440
Ifosfamide
2010
Completed Phase 4
~2980
Lenalidomide
2005
Completed Phase 3
~1480
Positron Emission Tomography
2008
Completed Phase 2
~2240
Tafasitamab
2016
Completed Phase 2
~180
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Who is running the clinical trial?
David Bond, MDLead Sponsor
3 Previous Clinical Trials
73 Total Patients Enrolled
3 Trials studying Lymphoma
73 Patients Enrolled for Lymphoma
David A Bond, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
1 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Lymphoma
30 Patients Enrolled for Lymphoma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I finished my lymphoma treatment over two weeks ago, except for steroids for symptom relief.My lymphoma has spread to my brain or spinal cord.My lymphoma started as CLL or SLL and has now transformed.I have had a solid organ transplant.I have had a bone marrow or stem cell transplant.I have not had a heart attack or stroke in the last 6 months.I have an infection that is not under control or needs IV antibiotics.My hemoglobin level is at least 8.0 g/dL, unless it's low due to my lymphoma.My diagnosis is a specific type of advanced B cell lymphoma.I have a history of serious blood clots and am not willing to take preventive treatment during the study.I can take care of myself but might not be able to do heavy physical work.I am a woman who can have children and have tested negative for pregnancy.I agree to use contraception and not donate sperm during and for 3 months after the study.I have issues with my digestive system that affect how I take or absorb medication.I agree to give my previous biopsy samples for this study.I have serious heart issues, including irregular heartbeat or severe heart failure.I haven't had major surgery in the last 4 weeks, except for diagnostic purposes.I have a rare hereditary sugar intolerance.I am 18 years old or older.I have been treated with anti-CD19 therapy or lenalidomide before.I have had one round of chemo-immunotherapy for my condition.I do not have active hepatitis B or C, or it is under control.I am a woman able to have children and agree to use birth control or not have sex during the study and for 3 months after.I have HIV with specific viral load counts or a resistant strain.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (tafasitamab, lenalidomide, ICE regimen)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research opportunity still available for enrolment?
"Per the clinicaltrials.gov database, this medical experiment is no longer active in terms of recruiting patients; it was initially posted on May 1st 2023 and most recently updated April 7th 2023. However, 2690 other trials are presently enlisting participants for their respective studies."
Answered by AI
What potential risks are associated with the tafasitamab, lenalidomide, and ICE regimen?
"Our team at Power rated the safety of tafasitamab, lenalidomide, and ICE regimen as a 2 due to its Phase 2 status; while there is evidence pointing towards this treatment's security profile, no data exists regarding its effectiveness."
Answered by AI
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